AURO-ARIPIPRAZOLE TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

ARIPIPRAZOLE

থেকে পাওয়া:

AURO PHARMA INC

এটিসি কোড:

N05AX12

INN (আন্তর্জাতিক নাম):

ARIPIPRAZOLE

ডোজ:

15MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

ARIPIPRAZOLE 15MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

30/50/100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

ATYPICAL ANTIPSYCHOTICS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0152514003; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2018-07-10

পণ্য বৈশিষ্ট্য

Page 1 of 71
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-ARIPIPRAZOLE
Aripiprazole Tablets
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral
House standard
Antipsychotic agent
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of initial Authorization:
July 10, 2018
SUBMISSION CONTROL NO: 257093
Date of Revision :
March 17, 2022
Page 2 of 71
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
03/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
.................................................................................................
2
Table of
Contents..........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................
4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4. DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................... 6
4.3 Administration
............................................................................................................
7
4.4 Reconsti